Klebanoff Mark A, Hauth John C, MacPherson Cora A, Carey J Christopher, Heine R Phillips, Wapner Ronald J, Iams Jay D, Moawad Atef, Miodovnik Menachem, Sibai Baha M, vanDorsten J Peter, Dombrowski Mitchell P
Department of Health and Human Services, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Am J Obstet Gynecol. 2004 Feb;190(2):363-70. doi: 10.1016/j.ajog.2003.08.020.
The purpose of this study was to determine the effectiveness of treatment over time for bacterial vaginosis in pregnancy and the probability of spontaneous resolution with placebo.
Women with asymptomatic bacterial vaginosis on Gram stain were assigned randomly at 16 to 23 weeks of gestation to receive two 2-g doses of metronidazole or placebo 48 hours apart and were re-evaluated for changes in Gram stain score on one occasion > or =2 weeks later.
Of 658 women who underwent metronidazole therapy, treatment was successful (score, <7) in 78% of those women who were seen at 2 to 3.9 weeks of gestation, which was similar to women seen > or =10 weeks after treatment. In 683 women who underwent placebo therapy, spontaneous resolution increased significantly from 13% at 2 to 3.9 weeks of gestation to 36% at > or =10 weeks of gestation. Spontaneous resolution was more common with lower vaginal pH or lactobacilli on Gram stain at the time of random assignment.
The effectiveness of metronidazole therapy of bacterial vaginosis persists for > or =10 weeks. Women who underwent placebo therapy had significant remission of bacterial vaginosis over > or =10 weeks. Remission was more common when the initial vaginal microbiologic disturbances were less severe.
本研究旨在确定孕期细菌性阴道病随时间推移的治疗效果以及使用安慰剂时自然缓解的概率。
革兰氏染色显示无症状细菌性阴道病的女性在妊娠16至23周时被随机分配,相隔48小时接受两剂2克甲硝唑或安慰剂治疗,并在≥2周后的某个时间重新评估革兰氏染色评分的变化。
在658名接受甲硝唑治疗的女性中,妊娠2至3.9周就诊的女性中有78%治疗成功(评分<7),这与治疗后≥10周就诊的女性相似。在683名接受安慰剂治疗的女性中,自然缓解率从妊娠2至3.9周时的13%显著增加到妊娠≥10周时的36%。随机分组时阴道pH值较低或革兰氏染色显示有乳酸杆菌的情况下,自然缓解更为常见。
甲硝唑治疗细菌性阴道病的效果持续≥10周。接受安慰剂治疗的女性在≥10周内细菌性阴道病有显著缓解。当最初的阴道微生物紊乱不太严重时,缓解更为常见。